Heart failure & cardiomyopathiesRandomised controlled trial

Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients

JACC Heart FailPublished

  • Randomised controlled trial
  • double-blind
  • placebo-controlled
  • multicentre (Nordic transplant centres)
  • Enrolled June 2019 to May 2022

Authors' conclusion

Twelve months of treatment with evolocumab substantially reduced low-density lipoprotein cholesterol but did not reduce maximal coronary intimal thickness in HTx recipients.

Study context

Population
Heart transplant recipients 4 to 8 weeks after transplantation at Nordic transplant centres56 vs 54 with matched IVUS pairs
Participants
128 recipients
Comparison
Evolocumab vs placebo
Primary endpoint
Baseline-adjusted maximal intimal thickness by intracoronary ultrasound
Follow-up
12 months

Primary result

Maximal intimal thickness

Adjusted mean difference

0.017 mm

95% CI −0.006 to 0.040

P = 0.14

Evolocumab vs Placebo
adjusted mean difference 0.017 mm (95% CI −0.006 to 0.040); P = 0.14

As reported in the abstract

Further findings

Outcomemean reduction (mmol/L) (95% CI)
LDL-C reduction1.11 (0.86–1.37)

Safety

Adverse events

Evolocumab not associated with an increase in adverse events

Original publication

Randomized Trial of Cholesterol Lowering With Evolocumab for Cardiac Allograft Vasculopathy in Heart Transplant Recipients. JACC Heart Fail. Published 26 June 2024. doi:10.1016/j.jchf.2024.04.026

Summarised from the published abstract; every number is checked against it